Stress and Fetal Brain Development | NCT03831126

Studies
Stress and Fetal Brain Development

NCT03831126

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

May 16, 2024Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Betamethason Sodium Phosphate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Feb 4, 2019

First Posted Date

Feb 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Detailed Description

Over the last decades there is growing evidence that increased maternal stress levels lead to an adverse effect on the physiological, metabolic and neuronal development of the fetus during gestation with possible long-lasting effects. Several studies showed that maternal stress also affects fetal endocrine processes during pregnancy and increases the risk for childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute stress related to the action of the artificial glucocorticoid betamethasone on fetal heart and brain activity. The fetal activity will be measured with biomagnetic sensors.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
betamethasone treatment			Drug: Betamethason Sodium Phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betamethason Sodium Phosphate	Drug	First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fetal and maternal heart rate	Measurement by fMEG	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
fetal and neonatal brain activity in response to auditory and visual stimuli	Measurement by fMEG	8 weeks

Other Outcomes

Measure	Description	Time Frame
blood sugar levels	Measurement by fMEG	8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

German speakers (fluently)
Gestational age between 28 and 34 weeks
Treatment with Betamethasone for improvement of fetal lung function -

Exclusion Criteria:

Smoking (regularly)
Alcohol and drug consumption during pregnancy
Congenital fetal disorders
Women with bed rest
acute depression or other psychiatric disorder (self report)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Pauluschke-Fröhlich, MD	Contact	07071 2983111		jan.pauluschke-froehlich@med.uni-tuebingen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen, Department of Women's Health	Recruiting	Tübingen		72076	Germany

Intervention Browse Module

MeSH Terms

ID	Term
C028994	betamethasone sodium phosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided